Recurrent Events Analysis of MASTER DAPT: Total Ischemic and Bleeding Events After Abbreviated vs Prolonged DAPT in HBR Patients
- PMID: 40406944
- DOI: 10.1016/j.jacc.2025.05.010
Recurrent Events Analysis of MASTER DAPT: Total Ischemic and Bleeding Events After Abbreviated vs Prolonged DAPT in HBR Patients
Abstract
Background: The effect of dual antiplatelet therapy (DAPT) duration on total events in patients at high bleeding risk (HBR) after percutaneous coronary intervention (PCI) is unclear.
Objectives: This study aimed to evaluate an abbreviated (median duration, 34 days) vs prolonged (median duration, 192 days) DAPT regimen on total events in 4,579 HBR patients from the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen) trial.
Methods: The MASTER DAPT coprimary outcomes at 335 days were as follows: 1) net adverse clinical events (NACEs), the composite of all-cause death, myocardial infarction (MI), stroke, and Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events; 2) major adverse cardiac and cerebral events (MACCEs), including all-cause death, MI, and stroke; and 3) major or clinically relevant nonmajor bleeding (MCB, type 2, 3, or 5 BARC bleeding). The differences between abbreviated and prolonged DAPT regimens were investigated using the Prentice, Williams, and Peterson model to account for recurrent events. Additional analyses were performed using the Andersen-Gill and Poisson incidence rate models.
Results: In the abbreviated DAPT (n = 2,295) arm of the trial, 214 NACEs occurred in 172 patients, compared with 227 NACEs in 182 patients in the prolonged DAPT arm (n = 2,284; HR: 0.95; 95% CI: 0.78-1.16; P = 0.64). A total of 156 MACCEs in 138 patients were observed in the abbreviated DAPT group compared with 160 MACCEs in 138 patients in the prolonged DAPT arm (HR: 0.96; 95% CI: 0.76-1.20; P = 0.69). Fewer total MCBs were observed in the abbreviated DAPT group (180 MCBs in 148 patients) compared with the prolonged DAPT group (240 MCBs in 211 patients, HR: 0.78; 95% CI: 0.64-0.94; P = 0.011). Abbreviated DAPT patients had significantly fewer total cerebrovascular accidents and fewer total strokes compared with the prolonged DAPT group (34 events in 32 patients, HR: 0.51; 95% CI: 0.28-0.91; P = 0.023; and 25 events in 24 patients, HR: 0.49; 95% CI: 0.25-0.98; P = 0.04, respectively). One MACCE in every 5 occurred after a bleeding event, and 1 bleeding event in every 25 occurred after a MACCE, thus emphasizing bleeding as a sentinel event.
Conclusions: A 1-month DAPT duration was associated with similar total NACEs and MACCEs and reduced total bleeding risk compared with prolonged DAPT. Providing a more comprehensive assessment of the total clinical burden, these findings support the use of an abbreviated duration of DAPT after PCI in HBR patients. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen [MASTER DAPT]; NCT03023020).
Keywords: DAPT; coronary syndromes; dual antiplatelet therapy; high bleeding risk; multiple events.
Copyright © 2025. Published by Elsevier Inc.
Conflict of interest statement
Funding Support and Author Disclosures The MASTER DAPT trial is conducted with support from Terumo. The study sponsor, the European Cardiovascular Research Institute (ECRI), Rotterdam, the Netherlands, a nonprofit organization, received grant support from Terumo for the conduct of the MASTER DAPT trial. The ECRI outsourced to the Clinical Trial Unit, Bern, Switzerland all statistical analyses of the present paper under a research contract agreement between the 2 institutions. None of the authors received personal or institutional payment for the present paper. Dr Bongiovanni has received grants and personal fees from Daiichi-Sankyo, Medtronic, Boston Scientific, Penumbra, and Vesalio not related to the submitted work. Dr Landi has received personal fees from Terumo outside the submitted work. Dr Heg is employed by the Department of Clinical Research, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees, this department is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations, and pharmaceutical and medical device companies provide direct funding to some of these studies. Dr Hildick-Smith has received personal fees from Terumo outside the submitted work. Dr Leonardi has received grants from AstraZeneca; and has received consulting fees from AstraZeneca, Daiichi-Sankyo, Bayer, Pfizer/BMS, ICON, Chiesi, and Novo Nordisk outside the submitted work. Dr Lesiak has received personal fees from AstraZeneca, Pfizer, and Terumo outside the submitted work. Dr Kala has served as a consultant for Abbott and Boston Scientific; and has received research support from Novartis. Dr Roffi has received institutional research grants from Cordis, Boston Scientific, Vascular Medical, Biotronik, and Terumo. Dr Vranckx has received consulting fees from Daiichi-Sankyo, Novartis, CSL Behring, and Bayer AG; has received honoraria from Daiichi-Sankyo and Servier; and has participated on the advisory board of Daiichi-Sankyo. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, Cardiovalve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or member of the steering/executive group of trials funded by Abbott, Amgen, Abiomed, Edwards Lifesciences, EnCarda, Medtronic, Novartis, and Sinomed, with payments to the institution but no personal payments; and has also served as a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Smits has received personal consulting or speaking fees from Terumo, Abiomed, and Opsense; has received grants and personal consulting fees from Abbott Vascular, Microport, and Daiichi-Sankyo; and has received grants from SMT. Dr Valgimigli reports grants and/or personal fees from AstraZeneca, Terumo, Alvimedica/CID, Abbott Vascular, Daiichi-Sankyo, Bayer, CoreFLOW, Idorsia, University of Basel Department of Clinical Research, Vifor, Bristol- Myers-Squibb, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, and PhaseBio outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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